Oridion Medical CAPNOSTREAM 20 Bedside Monitors Recalled for Settings Reset
Oridion Medical is recalling 144 CAPNOSTREAM 20 bedside monitors because date, time, and alarm settings may reset to factory defaults when powered off.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations or injuries, and the hazard involves a settings reset rather than a direct physical injury mechanism, fitting the Moderate criteria for a precautionary recall without reported harm.
Plain-English summary
Oridion Medical 1987 Ltd. is recalling 144 units of the CAPNOSTREAM 20 (INTL) N W/PRINTER bedside patient monitors, Part Number CS08658. The recall is due to a defect where the date/time, nurse call, and alarm settings may reset to factory default settings when the monitor is powered off.
The affected products were distributed nationwide in the United States and Puerto Rico, as well as to numerous foreign countries including Argentina, Australia, Austria, Bahrain, Belgium, Canada, and others. The source text does not report any illnesses or injuries associated with this defect.
Healthcare facilities should identify affected units by checking the specific lot codes provided in the recall documentation. Users should contact Oridion Medical for instructions on how to address the settings reset issue.
The recalled product
- Product
- CAPNOSTREAM 20 (INTL) N W/PRINTER, Part Number CS08658
- Manufacturer
- Oridion Medical 1987 Ltd.
- Category
- Medical Device — Patient Monitor
- Hazard
- Affected units
- 144
Distribution
Part of a larger recall action
This product is one of 37 recalled by Oridion Medical 1987 Ltd. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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